Global Drug Control: FDA Initiates Discussions on Nitrous Oxide and Potent Synthetics Ahead of WHO Assembly
In a bid to influence the forthcoming October session of the World Health Organization (WHO) Expert Committee on Drug Dependence (ECDD), the Food and Drug Administration (FDA) has opened the floor for public commentary on the prospective international regulation of various substances. At the core of these deliberations is the consideration of whether to subject a range of drugs, including nitrous oxide, a ketamine-like compound, synthetic opioids, and other substances, to global controls.
Nitrous oxide, often referred to as “laughing gas,” finds its usage both in medical anesthesia and recreational inhalation, popularly known as “whippits.” This compound currently lacks international and federal scheduling, although the United Kingdom has pursued its prohibition, prompting concerns from experts who advocated against such actions.
The FDA’s official notice clarifies, “Nitrous oxide (N2 O), recognized by aliases like nitrous, whippets, and NOS, emerged in the late 1700s as a dental and surgical analgesic. While FDA acknowledges its medical application, the gas has gained global popularity for its subjective effects.”
During the WHO ECDD assembly, member nations will evaluate the necessity of initiating a pre-review process for nitrous oxide—a phase determining whether the substance warrants a comprehensive “critical” assessment leading to potential scheduling decisions. Notably, the muscle relaxant carisoprodol also stands for potential pre-review.
Among the substances slated for critical evaluation, six others await scrutiny: benzodiazepines bromazolam and flubromazepam, the synthetic opioid butonitazene, stimulants 3-Chloromethcathinone (3-CMC) and dipentylone, and the dissociative 2-fluorodeschloroketamine (2-FDCK). Notably, none of these substances presently reside under international regulatory control.
FDA emphasizes that insights received on these compounds “will shape the U.S. Department of Health and Human Services’ (HHS) scientific and medical assessment, aligning with the WHO Questionnaire.” HHS intends to share this evaluation with the WHO, aiding their determination regarding international control or decontrol. The outcome of this decision could impact manufacturing, distribution, and necessitate specific record-keeping measures for these substances.
However, the FDA clarifies its role, stating it will abstain from recommending scheduling changes to the WHO until the organization presents its own suggestions to the United Nations (UN) Commission on Narcotic Drugs, projected for late 2023. Public commentary on these matters will be open until August 24.
This move by the FDA mirrors previous instances where the U.S. government welcomed public input on prospective WHO scheduling considerations. For instance, in 2021, the ECDD’s evaluation of kratom attracted tens of thousands of responses, ultimately resulting in the UN panel’s rejection of a ban on the substance.
The year 2020 witnessed the UN commission’s decision to reclassify marijuana and dismiss a WHO proposal to clarify the uncontrolled status of CBD containing up to 0.2 percent THC. This aligns with recent calls from a coalition of “special rapporteurs” appointed by the Human Rights Council to cease the global war on drugs.
